FDA Recall D-0207-2025

SHOPPERS- PLAZA · Hawthorne, CA

Class I — life-threatening Ongoing 514 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7

Lot / code: Batch # 001, exp. date 09/10/2026

Quantity: 172 180-count bottles

Reason for recall

Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

Recall record

Recall number: D-0207-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide via internet sales
Recall initiated: 2024-12-16
Classified by FDA Center: 2025-01-22
FDA published: 2025-01-29
Recalling firm: SHOPPERS- PLAZA
Firm location: Hawthorne, CA

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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